A Multi-Center Group to Study Acute Liver Failure in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986648
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : January 12, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh

September 29, 2009
September 30, 2009
January 12, 2016
January 2000
December 2015   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00986648 on Archive Site
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A Multi-Center Group to Study Acute Liver Failure in Children
A Multi-Center Group to Study Acute Liver Failure in Children
The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.
The PALF study group will collect clinical, epidemiological and outcome data on children with ALF. This information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. We believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. Biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. In addition, we hope to identify unrecognized mechanisms of liver injury resulting in ALF in children. Eligible study participants will be invited to participate in neurocognitive testing. Since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. Detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
whole blood, serum, tissue
Probability Sample
Children between birth and age 18 years who present with acute liver failure.
  • Acute Liver Failure
  • Hepatic Encephalopathy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent/assent
  • Birth through 17 years of age
  • Biochemical evidence of acute liver injury
  • Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)

    • The presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
    • If INR is at least 2.0, the presence of ENC is not required

Exclusion Criteria:

  • Known chronic underlying liver disease
  • Multi-organ system failure following heart surgery or ECMO
  • Solid organ or bone marrow transplantation
  • Acute trauma
  • Previously enrolled in the PALF Cohort Study
  • Other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom,   United States
1U01DK072146-01( U.S. NIH Grant/Contract )
U01DK072146 ( U.S. NIH Grant/Contract )
2U01DK072146-06 ( U.S. NIH Grant/Contract )
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University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert H Squires, MD Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
University of Pittsburgh
January 2016